Spend at least 50% of your food dollars on direct purchases from local farmers and artisans; with the remainder of your food dollars, you can celebrate how small the world has become!
This commitment to supporting local farms crowns the 20th year of the ongoing crusade by the Weston A. Price Foundation (WAPF) to disseminate accurate information on diet and health.
There is every reason to take the 50% Pledge, a campaign of WAPF to have its members spend at least half their food dollar purchasing food from local farmers and artisans.
By taking and making good on the pledge, you will be improving your own health and the health of your families. The highest quality food is mostly found from small farmers and artisans in the local food system. The likelihood is that you will be spending less money on doctors and medication. If you are currently spending little or nothing on medical services taking the 50% pledge is a great way to maintain that lifestyle.
Taking the pledge contributes towards small farm prosperity and increases the chances of your local food source remaining in business. There are still too many one-size-fits-all food safety regulations that squeeze regenerative family farms; they need all the business they can take on. The quality of the industrial food supply continues to deteriorate; by helping to keep quality local producers in business through your patronage, you will be better able to avoid health-robbing foods in the industrial system. The medical system currently accounts for 17% of our gross national product (GNP); reducing demand for medical services leads to a more productive use of resources. Small farmers are the true frontline healers in our healthcare system.
Taking the pledge will benefit the local economy by keeping more of your food dollar in the community. In many states, less than 10% of the food residents consume is produced in that state. The industrialization of agriculture has drained rural America.
Stronger local food systems lead to better food safety. At an international food safety conference in July 2019, a high-ranking FDA official stated that traceability was the Achilles heel of the food system; nothing is more traceable than food locally produced and consumed.
A country’s ability to be self-sufficient in quality food production is its first line of national defense. A strong small-farm sector marketing most of its production direct to the final consumer is the path towards making that happen.
There are other steps you can take beyond the 50% Pledge; you can pass word of the campaign on to non-WAPF members and convince them to take the pledge. Educate them on how important it is for their own health and the health of their families to have a prosperous local food system. The enemy is convenience; explain to them why it’s worth it to go the extra mile and purchase direct from local farms and artisans.
WAPF has created postcards explaining the 50% Pledge that are free for the asking to make people think more about where they are spending their food dollar. Request a free set of postcards through the online store at westonaprice.org or email a request postcards to email@example.com or call 703-820-3333.
The conventional food system is changing rapidly. The expansion of home delivery systems for industrial food, the growth of industrial organic, and the targeting of the traditional livestock business through plant-based and cell-cultured “meat” and “dairy” products threaten to weaken local food systems. Mass participation in the 50% Pledge campaign is a way to stem the threat, creating more demand for the raw dairy products, meat, poultry, eggs, produce and other nutrient-dense foods that small farmers and local artisans produce.
On October 21st and 22nd, Dennis and Alicia Stoltzfoos, owners of Full Circle Farm, went on trial at the Suwannee County Courthouse in Live Oak, Florida. The dairy farmer and his wife were both charged with one criminal misdemeanor for selling food without the proper permit. The couple represented themselves; their three-and-a-half-month-old daughter, Luanna, was at the defense table for much of the trial. Judge William F. Williams found Dennis and Alicia both guilty but deferred sentencing until April 14, 2020. On November 12, the Florida Department of Agriculture and Consumer Services (FDACS) piled on, filing an administrative complaint against the couple, proposing to fine them $3,000 for permitting and labeling violations. The Stoltzfooses have until December 4 to respond to the complaint.
With the way the trial turned out, applying the law to the Stoltzfooses’ situation was on trial as well. There have been a number of “what’s wrong with this picture” moments in the case since the state filed the charges in May, raising the question of why did this case have to go to trial. Dennis attended several pretrial hearings at which most of the cases before the court were for shoplifting along with possession or distribution of crystal meth or opioids; so, in the midst of a group of people charged with causing injury to others or themselves was a farmer and his wife both charged with activity that has made others well.
A trial like the Stoltzfooses’ would usually be held in a misdemeanor court room, but the crowd was too big; so, the trial was moved to a larger courtroom. For most misdemeanor cases, it’s typical to have two or three people present; at the Stoltzfoos trial, it was estimated that close to 100 people, including a number of children, were in the gallery. The first day of the trial, Judge Williams commented, “These kids are so much better behaved than I was at that age. My compliments to the parents of the kids.” The second day of the trial, the judge said, “My parents would have given their right arm for me to behave like that.”
While the state called no witnesses saying the food produced by Full Circle Farm (FCF) had made them sick, Dennis and Alicia submitted into evidence over 100 testimonials from customers on how FCF’s food had benefited their health.
State investigations are usually complaint-driven, but the state investigated the Stoltzfoos operation on its own initiative. There has never been a consumer complaint filed against FCF in all the years it has been in business.
Dennis had a prior run-in with the FDACS in 2005 over selling food without a permit; that case was settled when he agreed to obtain a Master Feed Registration that enabled him to sell pet food. He’s sold raw dairy products and other nutrient-dense foods under the registration [other than aged raw cheese, sales of raw dairy products in Florida are only legal for pet consumption]. Customers place orders on the farm’s website and pick up the orders at various delivery sites around north and west central Florida.
From 2006 until 2018, Dennis renewed the registration then let it lapse a year ago. In January of this year, an undercover agent from FDACS made a “buy” of raw milk and other foods from the farm, leading to criminal and administrative charges against farmer and wife.
Dennis admitted at the trial that he did not have a permit when the undercover officer made the purchase and, going forward, would obtain the permits he needed to be in compliance. He was negotiating with the state’s attorney right up to before the day of the trial to reach a settlement in which the charges would be dropped in return for Dennis obtaining the Master Feed Registration and submitting correct labels for the products he wanted to sell. Just 15 minutes before the trial was to start, the state’s attorney told him he would need to get a food establishment permit to sell at least some of the foods he lists on his website for human consumption as well. What foods the farm would have to sell for human consumption the attorney did not say.
There are a number of small farmers in Florida producing safe, nutritious food that, because of the costly requirements of producing and selling food for human consumption (i.e., installing bathrooms, triple sink, etc.), can only afford to sell their food for pet consumption. Those farmers cannot advertise pet food as being for human consumption but, at the same time, the producers have no legal responsibility to stop their customers from eating pet food. There is high quality human food being sold as pet food and people are seeking it out for their own health and the health of their families.
Dennis was a trailblazer in the 1990s in Florida for promoting the principles of the Weston A. Price Foundation (WAPF) and was one of the first Weston Price chapter leaders in the country. He is an educator and has been operating his farm as a healing ministry for nearly two decades, always looking for ways to produce the healthiest food possible. Dennis used the trial as an opportunity to educate the court on the need for changes in the law such that there would be no government interference with producers benefiting health and decreasing medical expenses through the sale of nutrient-dense food. In addition to introducing the customer testimonials as evidence, Dennis also submitted a copy of Joel Salatin’s book, Everything I Want to Do Is Illegal, to be a part of the court record. Judge Williams admitted the testimonials and the book as evidence, carrying the trial over to a second day so that he would have a chance to read both before rendering his verdict.
After Judge Williams found both defendants guilty, the prosecution asked the judge to sentence the defendants to six months probation, payment of $273 in court costs, and the payment of over $900 to FDACS for the cost of its investigation. The prosecution also asked that the court issue an order prohibiting Full Circle Farm from advertising food on its website and selling food until it obtained the required permits, a possible ‘death sentence’ for the farm given how long the licensing process could take. The judge responded to the state’s request by deferring sentencing for six months so that the Stoltzfooses would have enough time to get the needed permits. The crowd at the trial and the testimonials made the difference in the judge’s decision to defer sentencing.
One of the frustrations Dennis had with the labeling requirements was that his operation was transparent without having to have labels on his products. Customers order only through the farm website so they know what they are purchasing. The couple also has an open-door policy; people can call anytime they have questions or go to the farm to look around. Instead of spending $5,000 per year on labeling, why couldn’t that money go towards further enriching the soil on the farm?
The couple had surveyed its customers on labeling earlier, and the consensus was that the customers didn’t want labeling nor any other regulation. As the globalization of the food supply continues, it’s becoming more apparent that unregulated locally-produced food is safer and more nutritious than regulated food from the industrial food system, especially when that food is coming from countries with food safety systems that are substandard to the one in the U.S. Florida has found out how free ”free trade” is with greening disease, an imported malady that has devastated the state’s citrus industry. FDACS’s time would be better spent on imported food than on investigating farms like Full Circle that have never had a customer complaint. There is significant transparency in the operation of the farm without regulation.
The more local food producers there are in Florida, the safer the state’s food supply will be. Passing a law allowing for more unregulated sales from local producers direct to consumers would be the path towards that goal. It’s time for the legislature to consider doing so.
For the fourth time in 2 years, the North Dakota Department of Health (NDDH) is trying to water down the state cottage food law, also known as the 2017 North Dakota Food Freedom Act (FFA). The FFA allows the unregulated sale by producers direct to consumers except those foods that have either meat or raw dairy as an ingredient. NDDH has issued proposed regulations that would make illegal the unregulated sale of a number of foods that are currently legal under the 2017 law. In doing so, NDDH is overstepping its authority and is arguably hurting food safety; the proposed regulations are not about food safety–they are about control.
The FFA clearly states, “Notwithstanding any other provision of law, a state agency or political subdivision may not require licensure, permitting, certification, inspection, packaging, or labeling that pertains to the preparation or sale of cottage food products under this section….” Under the FFA, “cottage food product” means “baked goods, jams, jellies, and other food and drink products produced by a cottage food operator”; it was the NDDH that actually convinced the legislature to adopt this definition for the FFA. The legislature initially included the unregulated sale of raw dairy products in the FFA but pulled those foods out of the bill. The FFA excludes the sale of any uninspected products made from meat. There is no exclusion on any other foods in the FFA.
Shortly after the legislation passed in 2017, NDDH issued a guidance document for the FFA that prohibited the sale of a number of foods other than meat and raw dairy. FFA supporters didn’t abide by NDDH’s interpretation of the law; in 2018 the department followed up with proposed rules that would have again banned the unregulated sale of foods that are legal under the FFA. When food freedom proponents and members of the legislature defeated that effort, NDDH through its allies in the legislature introduced a bill in the 2019 session to roll back the FFA. The legislation, Senate Bill 2269 (SB 2269), as introduced would not only have prohibited the unregulated sale of a number of legal foods but also would have banned the unregulated sale of all drink products. The House of Representatives eventually killed the bill. SB 2269 represents the only legal attempt NDDH has made to dilute the FFA.
The proposed regulations have a number of the same changes that were in the bill that the legislature rejected. Among other things, the bill would have changed the law by making the unregulated sale of low-acid canned foods such as carrots, beets or beans illegal. The rules would prohibit the sale of unrefrigerated foods unless they are frozen–foods such as banana cream pie, potato salad, and carrot and celery sticks would all be affected. The proposed rules define “frozen foods” as foods maintained at temperatures no higher than zero degrees Fahrenheit.
The FFA allows the sale of all foods subject to time and temperature control other than those with meat or raw dairy as an ingredient. The proposed rules would limit the sale of time-and-temperature-control foods to baked goods (e.g., cream pies that are “frozen”) and home processed fresh-cut fruits and vegetables that are either “dehydrated or freeze-dried” or “blanched and frozen” ( i.e., no longer fresh).
The FFA specifically states that no government agency can require licensure for anything pertaining to the preparation of cottage food products, but that is what NDDH is trying to do in prohibiting the unlicensed sale of many foods that are currently legal to sell without a license. There are also labeling and certification requirements elsewhere in the proposed rules, both in violation of the FFA.
Beyond the proposed rules exceeding NDDH’s authority, what makes the department’s action a waste of taxpayer dollars is that in the two-plus years the FFA has been in effect, there has not been a single case of foodborne illness attributed to a producer operating under the state cottage food law. Cottage foods are thriving in the state, bringing in an estimated $1.5 million per year for producers and their families.1 The rules are a “solution” in search of a problem.
The experience of other states allowing the unregulated sale of time-and-temperature-control foods is similar to North Dakota. Towns in Maine have allowed the selling without regulation time-and-temperature-control foods direct from producer to consumer other than meat and poultry as far back as 2011 under local food sovereignty ordinances; no case of foodborne illness has been attributed to any producer operating under the ordinance. Under the Wyoming Food Freedom Act, producers in that state can sell any food product other than meat without regulation; in the 4-1/2 years since the law went into effect, no one operating under the Act has been found to make anyone sick. The same goes for the Utah Homemade Food Act which went into effect over a year-and-a-half ago, that Act allows the sale of all foods other than meat and raw dairy from the producer direct to the consumer without regulation.
The track record in these states indicates that NDDH’s proposed rules would hurt food safety in North Dakota if they become law. Some producers currently selling under the FFA will not be able to afford the cost of compliance if a license is required for the foods they sell require; others currently producing safe and nutritious food will stop if the law requires them to get a license because they don’t want a government inspector in their home kitchens. Fewer local producers will likely result in more purchases of industrial food which has a higher rate of foodborne illness outbreaks then foods produced under the FFA. The more producers operating under the cottage food law the better the public health is served. Instead of trying to dilute the FFA, there are ways NDDH could be spending taxpayer dollars productively to work with cottage food producers. Farmer LeAnn Harner, a leader in the North Dakota Food Freedom Movement, pointed out that the department could help provide education, equipment, and free testing of recipes to cottage food producers.2 The more cottage food producers there are, the safer the food supply, the stronger the local economy, the more self-sufficient communities will be in food production, and the better the health of North Dakota residents.
NDDH has a chance to be an agency that promotes the production and sale of nutritious food rather than being a bureaucracy that restricts it or, in the words of North Dakota Representative Daniel Johnston (R-Kathryn), “the Department of Control”.3
North Dakota residents have until October 12th to comment on the proposed rules. It is important to call and or email NDDH asking that they withdraw the proposed rules. The phone number for the Division of Food and Lodging is 1-701-328-1291 or 1-800-472-2927; the email address is firstname.lastname@example.org.
Please take action now.
If you are a producer affected by the proposed rules, let NDDH know what products you sell and how the Food Freedom Act has helped your business.
Consumers should let NDDH know what healthy nutrient-dense products the Food Freedom Act has enabled them to purchase direct from producers.
 Harner, LeAnn. “Testimony of Cottage Food Rules”. North Dakota Department of Health hearing on proposed rules, Bismarck, North Dakota. October 2, 2019.
The International Association of Food Protection (IAFP) held its annual meeting in Louisville July 21-24 at the Kentucky International Convention Center. Over 3,800 food safety professionals from industry, federal and state regulatory agencies and academia (students and faculty) attended this year’s meeting.1
Food safety continues to be a growth industry. In spite of the Food Safety Modernization Act (FSMA) and various food safety measures undertaken by the United States Department of Agriculture (USDA), foodborne illness outbreaks in the U.S. have not declined much, if at all. One of the sessions at the meeting was titled “Why Are We Still Having Food Safety Failures If We All Have Food Safety Systems?”2 Globalization and a deterioration of quality in the industrial food system remain as drivers of the food safety industry. Recently, USDA issued a proposed rule to allow the import of poultry slaughtered in China.
The IAFP meeting is a huge networking event with a friendly and collegial atmosphere for attendees. Food safety troubles represent a substantial business opportunity and enable IAFP to serve as an incubator for the development of food legislation, like FSMA, which advances the financial position of each of the groups attending IAFP. The way this works is that the industrial food companies cause the food safety problems, Congress increases the budget of the U.S. Food and Drug Administration (FDA) and USDA to deal with these problems, then part of that budget increase goes to academia for grants to come up with solutions for the problems and another part goes to state agencies in grants to do the Fed’s bidding (e.g., state inspections to enforce the new federal laws); further, the newly legislated requirements give labs and other firms involved in food safety more revenues, and the industrial food companies get one-size-fits-all food safety regulations that increase their market share when their smaller competitors cannot afford the cost of compliance.
One sector that is not a part of the food safety trail of revenue is the local food system. Regulators, industry and academia have done some great work dealing with problems in the industrial food system but they have never acknowledged how a stronger local food system can improve overall food safety. So the question is: if the small farmers and artisans making up the local food system don’t have a place at the table, are they on the ‘menu’ for the players in the food safety industry? For now, it looks like local food producers still have ways of staying off the ‘menu’ but the food safety industry is monitoring them, possibly considering ways to get them more under the industrial food regulatory umbrella.
During a roundtable session at IAFP titled “Cottage Foods — Harmonizing Food Safety Practices for a Growing Entrepreneurial Industry”3, regulators on the panel expressed some frustration at the lack of uniform regulation for cottage foods in the U.S. but none of them indicated that legislation to make state cottage food laws the same would have any traction.
There was also a panel for the topic, “Has the Time Come for the Complete Adoption of the Food Code?”4 The Food Code is a set of onerous model regulations that FDA develops to govern retail sales of food to the consumer. All states have adopted at least some portion of the Food Code but full adoption would mean the repeal of laws in states such as Wyoming, Maine, Utah, and North Dakota that currently allow unregulated sales from producer direct to consumer of foods needing time and temperature control (e.g., dairy and foods with dairy as an ingredient). Again, no one on the panel for this presentation stated there was a legitimate chance that this kind of legislation would pass.
The most alarming news at the conference was the disclosure by an FDA official regarding the agency’s inspections of food facilities for compliance with Current Good Manufacturing Practices (GMPs) which are one-size-fits-all regulations governing plant construction and design, sanitation, and warehousing and distribution. Producers with less than $1 million in sales per year come under the Tester-Hagen qualified exemption and are to be exempt from FSMA requirements for a food safety plan and, arguably, from the GMPs. Nonetheless, assumed as part of its duties under FSMA, FDA has been conducting GMP inspections of these exempt facilities anyway. A reading of the relevant FSMA statute indicates that FDA doesn’t have the authority to require compliance with GMPs by firms under Tester-Hagen. The typical FDA inspection for GMP compliance can last 2-½ to 3 days. [see “Is FDA Exceeding FSMA Inspection Authority”]
FSMA provides an absolute exemption from the food safety plan requirement for those producers who derive over half of their sales revenues from direct-to-consumer transactions. Most small farmers and local artisans fit this description, but expanding their sales to restaurants and retail stores is a step many of them need to take to increase business. The unauthorized FDA inspections for GMPs make that a more difficult road to travel if their direct-to-consumer sales fall below half of their total revenue.
A growing local food system can make the food safety regulators’ jobs easier. At the IAFP meeting, a high-ranking FDA official acknowledged that the “Achilles heel” of the food safety system is the lack of traceability for industrial food, an admission that isn’t surprising given the international food trade and the long complex supply chains that result. Nothing is more traceable than locally-produced and -consumed food. Deregulating local food producers and increasing their numbers is the path to fewer foodborne illness outbreaks and safer, more nutritious food.
Instead of FDA inspectors and state regulators spending a few days on the premises of small producers, they could invest their time more productively by inspecting imports. One speaker at the meeting displayed a graph showing that from 2009-2016 the greatest number of foodborne illness outbreaks were caused by seafood (25%) followed by produce (15%).5 It is estimated that 90% of the seafood consumed in the U.S. is imported6; a 2018 article citing USDA data on produce for 2016 estimated that 53% of fresh fruits and 31% of fresh vegetables are imported7.
Over 8 years after passage, FSMA is now close to being fully operational. A food law attorney speaking at the meeting observed that FDA was getting more strict on its interpretation of the FSMA requirements. The attorney also noted that FDA inspectors are called “investigators”, meaning that their purpose is primarily to find problems in a food facility they inspect rather than working with the facility to assure compliance with the law. The unstated goal of FSMA has always been to consolidate the food supply.
With the way the law now stands, the key for local producers to survive FSMA over the long-term is to educate the public on how the most safe, nutritious food is found in the local food system. It is the best way to stay clear of a regulatory scheme that can put producers providing nutrient-dense food out of business. More retail outlets will be adopting requirements similar to those in FSMA for producers wanting to sell to them.
The Weston A. Price Foundation (WAPF) has started a campaign to encourage its members to spend at least 50% of their food dollar purchasing raw dairy, meat, poultry, eggs, and produce direct from local farmers and artisans. For improved public health and the viability of producers in the local food system, buying more food directly from local producers is a critical step for consumers to take.
1. International Association of Food Protection, “Annual Meeting”. Statement: “The IAFP Annual Meeting is attended by more than 3,800 of the top industry, academic and governmental food safety professionals from six continents.” Accessed 6 Sep 2019 at https://www.foodprotection.org/annualmeeting/
2. Prince, G., S. Crowley, and N. Anderson. S11: Why Are We Still Having Food Safety Failures If We All Have Food Safety Systems? Annual Meeting of the International Association for Food Protection. Louisville, KY. Symposia. July 22, 2019
3. Andress, E., E. Ceylon, E. Edmunds, J. Eifert, S. Giovinazzi, and A. Snyder. Cottage Foods: Harmonizing Food Safety Practices for a Growing Entrepreneurial Industry. Annual Meeting of the International Association for Food Protection. Kentucky International Convention Center, Louisville, KY. Roundtable RT15. July 23, 2019
4. Bryant, V. D. Detwiler, J. Horn, G. Lewis, and A.M. McNamara. Has the Time Come for Complete Adoption of the Food Code?, Annual Meeting of the International Association for Food Protection. Kentucky International Convention Center, Louisville, KY. Roundtable RT16. July 23, 2019.
5. Sayler. A. “FDA’s FSMA Enforcement Impact on Non-U.S. Food Manufacturers – Examples: Food Retailer: Examples, Case Studies and Recommendations”, Tracking FSMA Quantitative and Qualitative Impacts on the Food Industry Under Full FDA Enforcement – Stats, Trends, Challenges and Lessons Learned. Annual Meeting of the International Association for Food Protection. Kentucky International Convention Center, Louisville, KY. Symposia S1, 4th Presentation, Slide #4, “CDC Foods Causing Foodborne Illness 2009-2016”. July 22, 2019.
6. NOAA Fisheries, “Fisheries of the United States, 2012: A Statistical Snapshot of 2012 Fish Landings. National Oceanic and Atmospheric Administration”, 2013, p. 4. Accessed at https://www.st.nmfs.noaa.gov/Assets/commercial/fus/fus12/FUS_2012_factsheet.pdf
7. Karp, D. “Most of America’s Fruit Is Now Imported. Is That a Bad Thing?” New York Times online, 13 March 2018. Accessed at https://www.nytimes.com/2018/03/13/dining/fruit-vegetables-imports.html
FDA has compiled statistics for the first half of 2019 on the number of inspections it and state regulatory agencies under contract to FDA have conducted pursuant to the Food Safety Modernization Act (FSMA).1 What stands out in the numbers is that by far, the most inspections FDA has conducted has been for compliance with Current Good Manufacturing Practices (GMPs).2
The GMPs are a one-size-fits-all regulatory scheme that includes requirements for plant construction and design, equipment, sanitation, and warehousing and distribution; GMPs are broadly worded and subject to varying interpretations by inspectors. According to an FDA official who spoke at the recent annual meeting of the International Association for Foods Protection (IAFP), some of those inspections for GMP compliance were for firms under the Tester-Hagan exemption that removes the requirement of having a food safety plan (known as HARPC or Hazard Analysis and Risk-based Preventive Controls). The average inspection for the GMP requirements is 3 to 4 days; if the firm has a compliance history with FDA, that inspection could be as long as 7 to 9 days.3 Arguably, FDA has no legal authority under FSMA to conduct GMP inspections of most or all of the Tester-Hagen exempt firms.
Among other requirements, FSMA requires facilities engaged in processing, manufacturing, packing, or holding food to have a written food safety plan showing that the facility
has identified the potential hazards associated with the food being produced, packed, or held;
has implemented preventive controls to address the hazards; and
is monitoring the performance of the preventive controls to ensure that such controls are effective.
This requirement for HARPC is found in 21 CFR 117 Part C.
HARPC for human food has several exemptions from its mandates, one of which is a “qualified exemption for those firms grossing less than one million dollars per year 4, an exemption known as Tester-Hagen. In addition, to be eligible for the exemption, the facility must make more than half its sales either directly to consumers or to a restaurant or retail food establishment located either in the same state or within 275 miles of the facility.5
To obtain the exemption, facilities must submit a form to FDA that includes one of the following attestations:
that the facility has a modified food safety plan addressing most of the HARPC requirements [FDA could mandate that the food safety plan include GMPs]; or
that the facility is “in compliance with state local, county, tribal or other applicable non-Federal food safety law…including an attestation based on licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency such as a state department of agriculture, or other evidence of oversight.”6
A reading of the federal statute on HARPC, 21 USC 350g, shows how FDA could be exceeding its authority by inspecting those under the Tester-Hagen exemption for the GMP requirements; 21 USC 350g(L)(2)(A) provides that a qualified facility “(A) shall not be subject to the requirements under Subsection (a) through (i) and Subsection (n) in an applicable calendar year….” Subsection (c) covers preventive controls, which is defined in Subsection (o) as:
“…those risk-based, reasonably appropriate procedures and practices, and processes that a person knowledgable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis conducted under subsection (b) and that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis. Those procedures, practices, and processes may include:
…(F) Current Good Manufacturing Practices under part 110 of title 21, Code of Federal Regulations (or any successor regulations).”7
NOTE: The Current Good Manufacturing Practices (CGMP) have since been moved to the HARPC section (part 117).
Most, if not nearly all, facilities exempt by Tester-Hagen would obtain the exemption by attesting that their business is subject to some kind of state regulation. Why spend that time and resources drawing up a modified HARPC plan when you can get the exemption by sending FDA a copy of a state license or other proof of state oversight?
The only food business that would not be subject to state regulation would be those selling only direct to consumers; those firms would not have to register as food facilities and, therefore, would not have to be subject to any of the FSMA requirements for HARPC if over half of their gross revenues are from direct-to-consumer sales in which case they would be exempt as a “retail food establishment” under federal regulation.8
FDA hasn’t divulged how many facilities with a qualified exemption it has inspected but it looks like it has exceeded its authority if it has inspected any facility that obtained its exemption through an attestation that it was subject to non-federal regulation. To go from being allowed to include GMPs as a part of preventive controls regulations to issuing GMP rules under FSMA that are separate from preventive controls is a big reach. There was never any deliberation by Congress contemplating separate regulation of requirements for CGMPs as part of FSMA.
A food law attorney speaking at the IAFP conference observed that FDA is paying close attention to GMP compliance and has no tolerance for GMP violations. Given the length of GMP inspections, how FDA is interpreting the GMPs more strictly, and the number of enforcement tools the agency has which use to cripple a small business without the economies of scale to comply, it’s recommended that small farmers and local artisans have, if at all possible, over half of their sales as direct-to-consumer to be exempt from the food facility registration requirement. This includes firms currently registered; there is a procedure to cancel registration.9
The time to move is now; it looks like FDA’s interpretation of the FSMA requirements will only be getting more strict. The likelihood is that neither Congress or the court will exercise oversight to limit FDA’s inspection authority to what FSMA provides.
1. Bass, Glenn. US Food and Drug Administration. “FDA’s Perspective and Experience on FDA Enforcement and Inspection.” Symposia S1: Tracking FSMA Quantitative and Qualitative Impacts on the Food Industry Under Full FDA Enforcement – Stats, Trends, Challenges and Lessons Learned. Annual Meeting of the International Association for Food Protection, 22 July 2019. Speech, Kentucky International Convention Center, Louisville, KY.
2. Ibid. Out of nearly 9,000 FSMA inspections conducted, over 7,500 included assessing GMP compliance as well as HARPC (of which 7,000 were inspections for limited provisions of HARPC). Of the remaining, the FSMA inspections fell into the following categories: Sanitary Transport, Foreign Supplier Verification Program, Produce Safety Standards, HARPC for Animal Food, and GMPs for Animal Food.
4. 21 CFR 117.5
5. 21 CFR 117.3, see definition of “qualified end-user”
6. 21 CFR 117.201
7. 21 USC 350g(L)(2)(A)
8. 21 USC 350d, 21 CFR 1.226, 21 CFR 1.227
9. 21 CFR 1.241(c)
Seventeen states had bills legalizing or expanding the sale/distribution of raw milk and raw milk products before the legislatures during the 2019 session. Three states have passed legislation so far this year but, with many states in the first year of a two-year session, there are a number of bills that still have a chance of passing in 2020.
An untapped source of revenue for producers is the sale/distribution of raw dairy products other than milk and aged cheese. The sale of butter, cream, yogurt, and kefir is illegal in a majority of states but, given the excellent track record for food safety of all these products, there is a good chance that more states will be passing bills in the near future to legalize the sale of these products.
States having raw dairy bills in 2019 include:
The distribution of raw milk through herdshare agreements is currently legal by regulation; House Bill 16 (HB 16) would make it legal by statute and would also allow herdshare dairies to distribute all other raw dairy products to their shareowners in Alaska. HB 16 has passed out of the House and was assigned to a Senate committee before the 2019 session adjourned; so, it will start the 2020 session in the Senate Resources Committee.
Current law allows raw milk producers to sell up to a total of 500 gallons of raw goat milk and/or raw cow milk on an average monthly basis. House Bill 1699 (HB 1699) amends the law to also legalize the sale of raw sheep milk as part of the 500-gallon limit. HB 1699 passed the legislature and became law on April 10.
House Bill 1090 (HB 1090) will allow licensed dairies meeting sanitary standards to sell raw milk and raw cream to grocery stores, restaurants, and similar establishments. Under current law, licensed raw milk dairies can sell raw milk and cream on the farm and through delivery. HB 1090 has been referred to the House Agriculture Policy Committee. The Missouri legislature just finished the first year of a two-year session.
House Bill 490 (HB 490) would have legalized raw milk sales and created a two-tier system in which those producing ten gallons of raw milk per day would operate under a small-scale raw milk license while dairies producing more than ten gallons per day would need to obtain a commercial raw milk license. In effect, HB 490 would have acted as a de facto ban on raw milk.
Those producing more than 10 gallons per day would have had to have the dairy’s physical facility be up to Grade A standards, a cost of tens of thousands of dollars. Even small-scale raw milk dairies could have been subject to onerous physical facility requirements. The bill also could have subjected dairies to expensive testing requirements and have made them pay for costs of a foodborne illness outbreak investigation even if they weren’t held responsible for the outbreak. HB 490 died on the House floor vote.
Two other bills died without a hearing that, respectively, would have legalized herdshare agreements (House Bill 521 – HB 521) and would have legalized sales of raw milk and raw milk products by producers with herds of less than 10 cows, 20 goats, or 20 sheep (House Bill 516 – HB 516).
Under current law, producers can only sell raw milk and raw milk products where a county milk commission has specifically certified those foods; Nye County has the only county milk commission in the state. Senate Bill 418 (SB 418) would have allowed producers to sell statewide the raw milk and raw milk certified by a county milk commission. SB 418 also would have exempted micro-dairies [with up to 5 cows, 10 goats, 10 sheep] from certification standards and allowed them to sell raw dairy without regulation directly to the consumer at the farm where the milk is produced. SB 418 passed the Senate but died without a hearing in the Assembly Committee on Health and Human Services.
Sponsors introduced three raw milk bills in the 2019 session. House Bill 103 (HB 103) would allow the licensed sale of raw milk in retail stores by dairies with no more than 10 lactating cows, 10 lactating goats, or 10 lactating sheep. Companion bills, Senate Bill 509 (SB 509) and House Bill 385 (HB 385), would ban herdshare agreements; the state legalized the distribution of raw milk and raw milk products through herdshare agreements as part of the 2018 North Carolina Farm Bill. None of the three bills have received a hearing but the legislature’s rule allows bills to be tacked on to unrelated legislation; this is what happened in 2004 when the legislature passed a herdshare ban at the end of the session. As long as the legislature is still in session, SB 509 and HB 385 remain dangerous.
Assembly Bill 5867 (AB 5867) would legalize herdshare agreements, referred to in the bill as “shared animal ownership agreements”, without regulation. Currently, in New York, the licensed on-farm sale of raw milk is legal. AB 5867 has been referred to the Assembly Agriculture Committee.
There were several raw dairy bills before the legislature. Senate Bill 358 (SB 358) which allows the sale of raw butter by producers with a dairy plant license became law on April 30; the bill requires dairy plant operators to keep the butter-making separate from the production of other dairy products. Producers must also put a warning label on the packages containing the raw butter.
Senate Bill 15 (SB 15) would have banned herdshare agreements; the bill died because no companion House bill was introduced. The sponsor of SB 15 later tacked on an amendment to an unrelated bill, Senate Bill 1123 (SB 1123), but that bill died in committee. Current law allows the unregulated distribution of raw milk and raw milk products through herdshare agreements.
The final version of House Bill 182 (HB 182) would have allowed licensed dairies to sell raw butter and raw cream; currently, the only raw dairy products licensed producers can sell are milk and aged cheese. HB 182 passed out of the House and the Senate committee, but time ran out on the 2019 session before a vote of the full Senate could take place.
House Bill 525 (H.525) became law on June 17. Among other things, the bill legalizes the sale of raw milk at consumers’ homes and at farmers markets if the producer is in compliance with statutory requirements for animal health, sanitation, labeling, recordkeeping (as well as signage and registration requirements for those selling at farmers markets). Prior to the passage of H. 525, those producers meeting the same requirements could sell milk only on the farm and then deliver it to their customers (either at their homes or at farmers markets).
On May 23, Representatives Thomas Massie (R-KY) and Chellie Pingree (D-ME), and Senator Angus King (I-ME) reintroduced the Processing Revival and Interstate Meat Exemption Act (H.R. 2859 / S. 1820), also known as the PRIME Act. The legislation would return power to the states to determine appropriate regulations for meat processing within their borders. The bills have been referred to the House Committee on Agriculture and the Senate Committee on Agriculture, Nutrition and Forestry, respectively.
The PRIME Act would give states the option of passing laws to allow the sale of custom-slaughtered and processed meat in intrastate commerce direct to the consumer and to venues such as restaurants, hotels, grocery stores, and boarding houses. Federal law currently prohibits the sale of custom-processed meat; meat from a custom facility can only go to the individual or individuals who own the animal at the time slaughter takes place–a requirement costing farmers a substantial amount of business. Many potential customers either don’t have the funds to buy a whole animal or the freezer space to store it.
Farmers who sell meat by the cut must use a slaughterhouse that has an inspector present during the actual slaughtering. Many communities in the U.S. have custom facilities nearby but not inspected slaughterhouses; this means hauling the animals several hours to an inspected facility, driving up the farmer’s costs and stressing the animals. There are places in this country where the farmer has to book a year in advance with the slaughterhouse under inspection for the slaughtering of livestock.
The decline in slaughterhouse infrastructure since the passage of the Wholesome Meat Act in 1967 has been one of the biggest problems small farmers face. The Wholesome Meat Act gave the federal government jurisdiction over meat processing and sales in intrastate commerce. At the time the Act passed, there were nearly 10,000 slaughterhouses in the U.S.1; as of January 1, 2019, there were 2,766.2
Passage of the PRIME Act is more important than ever. There continues to be growing demand for grass-fed beef, but with the lack of local slaughterhouses, small farmers are missing out on much of that business. Instead of business that could go to small American farmers, imported “grass-fed” beef has the dominant market share in the U.S. According to reports, 75% to 80% of grass-fed beef sold in this country is imported. Due to lax country-of-origin-labeling laws, much of this meat is labeled as being produced in the U.S.3
It remains to be seen how much market share laboratory plant-based “meat” will capture at the expense of small-scale livestock farmers, but the fake meat industry is growing rapidly at this time with support from major Wall Street banks and investment firms [see underwriters listed in the prospectus for Beyond Meat, Inc.4].
Small farmers badly need greater access to slaughterhouses to be able to compete on more even footing with agribusiness. Currently, only four companies control over 80% of the beef processing in this country; four companies control over 60% of pork processing.5
The meat industry consolidation has led to significant food safety concerns. Inspected slaughterhouses are stretched beyond capacity. In recent years the industry has had over 100 recalls each year totaling over 20,000,000 pounds of meat and poultry products being recalled annually.6
Few, if any, recalls and cases of foodborne illnesses have involved meat slaughtered and processed at a custom facility. Custom slaughterhouses are generally small facilities where often only a few animals are slaughtered and processed each day; contrast this with the USDA plants where up to 300-400 cattle are slaughtered per hour.7 The custom houses, even without an inspector on site, have a much better track record for food safety. Passage of the PRIME Act will improve food safety in the industry.
Representative Massie said,
“Consumers want to know where their food comes from, what it contains, and how it’s processed. Yet federal inspection requirements make it difficult to purchase food from trusted local farmers. It is time to open our markets to give producers the freedom to succeed and consumers the freedom to choose.”8
The PRIME Act was originally introduced in 2015. In the House, H.R. 2859 and currently has eleven co-sponsors; the Senate companion bill, S. 1620 has two co-sponsors.
Please support this crucial legislation. The Weston A. Price Foundation (WAPF) will be sending out an alert on the PRIME Act in the near future.
On April 30 Governor Bill Lee signed into law Senate Bill 358 (SB 358); the legislation legalizes the sale of raw butter by licensed producers in Tennessee. SB 358, sponsored by Senator Frank Niceley, a long-time champion of the small farmer and local food, goes into effect immediately.
SB 358, as amended in the House and passed, provides that
“the department [of agriculture] shall not regulate the production of unpasteurized butter provided that it is produced:
(A) In a facility separate from production of pasteurized products;
(B) Solely for intrastate commerce; and
(C) By a person licensed by the department as a dairy plant.
On any raw butter sold, the bill also requires a warning label stating, among other things, that the product has not been inspected and that butter “may contain disease-causing micro-organisms.”1
According to the Centers for Disease Control (CDC), between 1998 and 2016, there was not a single foodborne illness outbreak attributed to the consumption of commercially-produced raw butter2; during that time, California-based Organic Pastures Dairy Company (OPDC) sold over two million pounds of the product without incident3. The labeling requirement was a concession that had to be made if the bill was going to pass.
It’s not clear why the Tennessee Department of Agriculture (TDA) would not regulate the production of butter from a licensed dairy plant but the answer could possibly be because of some agreement the department has with the federal government.
SB 358 allows the retail sale of raw butter; Tennessee joins Arizona, California, Idaho, and Maine as states allowing the sale of the product in retail stores. There are around a dozen states that allow the sale or distribution of raw butter for human consumption.
Niceley introduced a bill in 2018 that would have legalized raw butter sales, but that legislation didn’t make it out of House committee after passing the Senate. With the accelerating decline of the state dairy industry over the past year, SB 358 did not have any significant opposition. One point Niceley made during consideration of the bill was about the increasing competition from lab-grown dairy products to the conventional industry, saying that laboratories could produce pasteurized dairy products at a much lower price than the dairy industry could and that the industry needed to separate itself from that competition with the production and sale of raw dairy products.
It is uncertain at this time how many of the state’s licensed dairy plants are interested in selling raw butter but the potential is there. None of Tennessee’s neighbors allow raw butter sales; there could be out-of-state customers buying butter in Tennessee. Cheesemakers from other states could be moving in with an additional high-demand product to sell. If demand does take off, some of the state’s remaining dairies could obtain higher prices for their milk by selling some of their production to dairy plants instead of cooperatives where most are losing money with each load they ship.
The Farm-to-Consumer Legal Defense Fund (FTCLDF) has a citizen petition4 before the U.S. Food and Drug Administration (FDA) to lift the interstate ban on sales and distribution of raw milk and other raw dairy products (except aged cheese). If the petition is successful, it is likely raw butter sales would be legal in all states within a few years. Until that time, there should still be a steady increase in states allowing raw butter sales or distribution.
Brentwood Chapter Leader Shawn Dady lobbied for the bill on behalf of the Weston A. Price Foundation (WAPF). Congratulations to her, Senator Niceley, and the other Tennesseans supporting SB 358 for legal raw butter sales5, in time for the spring flush.
 House Amendment Number 1 to HB0532 (HA0116), Tenn. House § 1 (2019). Last accessed 5/7/2019 at http://www.capitol.tn.gov/Bills/111/Amend/HA0116.pdf
 Mark McAfee and Farm-to-Consumer Legal Defense Fund, “Citizen Petition Seeking Legalization of Interstate Transport of Unpasteurized Butter”, petition, June 22, 2016; p. 10
 Ibid. p. 11
 For more details about the citizen petition, read “FTCLDF Hires Jim Turner to Litigate Raw Butter Petition” at https://www.realmilk.com/turner-litigate-raw-butter-petition/
 Thanks to an opinion from the Attorney General, the state has allowed the distribution of raw butter and other dairy products since 2012 through herdshare agreements.
Raw milk enforcement actions continue in Canada; this time it’s Alberta. The Crown has brought three charges against Innisfail farmer David Rand for alleged violations of Alberta’s dairy law: the unlicensed production or processing of dairy products, selling raw milk, and “obstructing, hindering or impeding an inspector in carrying out their duties” under the Alberta Dairy Industry Act. A trial will likely take place this fall; each of the charges carries a maximum $25,000 fine. [For those who would like to support Rand, a GoFundMe campaign has been set up at ca.gofundme.com/dairy-freedom.]
In addition to the charges, the Alberta Health Services (AHS) has issued a “Notice of Closure” to Rand ordering him to “cease and desist the distribution, transport, processing or sale of unpasteurized milk or unpasteurized milk products.” One of the grounds for the order was that “distributing, transporting, processing or selling unpasteurized milk products” was in violation of an Alberta health regulation stating, “no person shall create, commit or maintain a nuisance.” Alberta Agriculture and Forestry (AAF) issued a second order to Rand, a “Notice of Seizure or Detention” requiring that all milking equipment and any dairy products, including all future production, remain on Rand’s farm.
The charges and the orders against Rand stem from a November 7, 2018, raid on Rand’s farm and a supposed raw milk distribution site in Red Deer, Alberta, by officials from both AAF and AHS as well as the Royal Canadian Mounted Police (RCMP). The officials conducted the raid at both locations without any warrant.
The law in Alberta, as in all provinces of Canada, prohibits any sale of raw milk; there is a federal ban in the country as well. The ban has served as a protection racket for dairy industry but some of the farmers making up the industry might want to consider obtaining another outlet for their milk. The Canadian quota system has been held as a model for the struggling U.S. dairy industry but there has been a tremendous decline in the number of Canadian dairies, falling from nearly 140,000 in 1960 to fewer than 12,000 today according to The Globe and Mail.1
In Ontario, there is an ongoing court case where 21 Ontario farmers and consumers have filed in a Toronto Superior Court a constitutional challenge to the province’s ban on raw milk sales and distribution.2 In 2010 an Ontario court ruled in a case the Crown had brought against Michael Schmidt for illegally selling raw dairy that there was a legal distinction between the public and private distribution of food and that informed consumers can waive the protection of public health laws. That ruling was reversed on appeal; raw milk proponents could use a similar decision in the country that is the most oppressive in the world when it comes to enforcement against raw milk sales and distribution.
Supporters of raw milk access in Canada may go to the educational Facebook page for Farm-Fresh-Milk (be sure to include the hyphens). The intention is to show that raw milk needs to be on the policy platform of every party. There is also a website with a petition for Canadians to have the right to obtain fresh milk produced by local farms recognized by the legislation; to endorse “We Choose Fresh” petition, go to www.farmfreshmilk.ca/wechoosefresh.
Various media have been waging one of the bigger anti-raw milk propaganda campaigns in memory through their reporting on a recent individual case of brucellosis attributed to raw milk consumption. The media are using the case of the third individual incidence of brucellosis blamed on raw milk consumption in the past year and a half to warn the public that people are putting their health in jeopardy if they don’t consume milk that is pasteurized. The illnesses occurred in Texas in August 2017, New Jersey in October 2017 and New York in November 2018 with the latest illness blamed on Miller’s Biodiversity Farm of Quarryville, Pennsylvania; there is currently a quarantine in effect prohibiting the farm from distributing raw dairy products. A cow that tested positive for Brucella has been removed from the dairy herd.
The media have been taking their cues from press releases issued by public health departments that have been giving the advice to pasteurize all milk. However, the solution to avoid getting brucellosis is far different from what public health and the media are telling you. In the words of one healthcare professional, “For public health officials to issue public notices that the solution to this avoidable problem is to pasteurize all milk, is astonishing.”
First off, the three cases of brucellosis are the only known cases attributed to raw milk consumption over the past 20 years. Brucellosis is a systemic disease in cattle and humans that is caused by the bacteria Brucella abortus. At one time the disease in cows caused severe reductions in offspring and was a problem for the cattle industry. A national eradication campaign was launched in the 1950s and, according to USDA statistics, the number of cattle/bison herds affected by brucellosis in the U.S. has been less than 10 every year from 2003 onward.1
The eradication program’s success has led to a huge decline in the number of brucellosis cases in humans; estimates are that there are about 100 cases of human brucellosis per year in this country.2 In the U.S. this is mainly an occupational disease with most of the rare cases of brucellosis being in people who attended the birth of an infected cow and then became infected during handling of the birth tissues and fluids.3,4
In an infected dairy cow, the Brucella abortus pathogen can proliferate in the mammary glands and then enter the milk. The pathogen can pass to humans when drinking the infected milk but, as mentioned, the cases of brucellosis (also known as undulant fever) attributed to drinking raw milk in the U.S. are extremely rare.
The “milk ring test” is the traditional and commonly used method to screen dairy herds to detect any cows with brucellosis; the test is performed on the herd’s milk to check for the rare presence of Brucella antibodies.
Two vaccines against brucellosis have been developed for calves: the S19 vaccine and the RB51 vaccine. The S19 vaccine is effective but it has the disadvantage of causing testing for antibodies to become positive. The vaccine can make it difficult to distinguish between a vaccinated cow and an infected cow. The RB51 vaccine does not cause the antibody testing of cows to become positive but another problem arises with its use.
The RB51 vaccine must be administered to calves before they become fertile; a side effect is that, if a cow is given the RB51 vaccine when pregnant, it may actually cause an infection with the vaccine strain of Brucella in the vaccinated cow. It is, therefore, possible that if the RB51 vaccine isn’t given strictly according to the protocol, the vaccinated cow may become infected and may shed the pathogen (i.e., the RB51 strain of Brucella) into the milk.
Public health officials have found in all three cases of illness from brucellosis attributed to raw milk consumption, the strain of Brucella abortus discovered in the three individuals was the RB51 vaccine strain. In fact, in November 2017, the Pennsylvania Department of Agriculture sent a letter to licensed raw milk producers in the state advising them to stop immunizing cows from brucellosis with the RB51 vaccine.5
So the solution to preventing brucellosis in raw milk is not for producers to pasteurize the milk but rather to either stop giving their herd the RB51 vaccine or to make sure their vets give the calves the vaccine before the calves become fertile. Worth noting, too, is that hundreds of people drank raw milk produced by the herds responsible for the three cases of brucellosis and, as far as is known, no one else became sick.
In the meantime, the media fear-mongering continues on. The latest case of brucellosis attributed to raw milk consumption dates back to November 2018, but to read the stories in the media, you would have thought it was just discovered. CDC press releases on this latest case dated January 23, 2019, and February 11, 2019, are providing the impetus for the flood of media reports.
Has an agenda ever gotten so much mileage over three illnesses?
A fear-inciting statement from the February 11 CDC press release that the media have parroted is, “the CDC and state health officials are investigating potential exposures, to Brucella strain RB51 in 19 states, connected to consuming raw (unpasteurized) milk from Miller’s Biodiversity Farm in Quarryville, Pennsylvania.”6 (The farm allegedly distributed raw milk to people in the 19 states listed later in the release.) Being exposed to a pathogen is far different than being sickened by it; we are exposed to various pathogenic bacteria such as listeria and e. coli in the environment every day.
One headline screamed, “Deadly Disease Caused by Raw Milk Has Already Put 19 U.S. States on High Alert.”7 There have been no deaths from brucellosis attributed to raw milk consumption since the eradication program succeeded in substantially eliminating the incidence of the disease and possibly even long before then.
The public health agencies and their allies in the press have been misleading the public long enough on raw milk and brucellosis. It’s time for fear and hysteria to give way to science and common sense.